CompletedPhase 2

Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab

United States19 participantsStarted 2012-08-31

Plain-language summary

This randomized phase II trial studies how well giving spironolactone works in preventing rash in patients with cancer that has spread to other places in the body and are receiving panitumumab and cetuximab. Spironolactone may prevent endothelial growth factor receptor (EGFR) inhibitor-induced skin rash.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Scheduled to start panitumumab or cetuximab; patients must not have been on the EGFR agent prior to randomization * Ability to reliably apply topical spironolactone/placebo twice a day to the face * Ability to complete questionnaire(s) by themselves or with assistance * For study 2 only, patients must be willing to avoid sun exposure for one month from registration * Creatinine =\< 1.5 x upper limit of normal (UNL) * For Study 2 only, ability to apply topical creams to the entire face and body Exclusion Criteria: * Prior allergic reaction or severe intolerance to spironolactone * Any rash at the time of randomization * Cutaneous metastases * Any other disorder that may predispose to hyperkalemia in the opinion of the treating oncologist * Use of topical corticosteroids at the time of study or their anticipated use in the next 8 weeks; (it is acknowledged that patients may be starting these agents pre-emptively as part of this protocol) * For study 2 only, previous intolerance of sunscreen or any of the other components of the Modified Preemptive Therapy Regimen (a moisturizer or oral doxycycline)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Patients Reporting a Grade 2+ Adverse Event Attributed to Spironolactone (Study I)

Timeframe: At 8 weeks

Incidence of Truncal/Extremity Rash of Any Grade in Patients in the Spironolactone Arm (Study I)

Timeframe: At 4 weeks

Percentage of Patients in the Spironolactone Arm Who Complete the 4-week Study Intervention (Study I)

Timeframe: At 4 weeks

Efficacy of the Spironolactone Treatment to Prevent/Attenuate Rash From EGFR Inhibitors in This Patient Population Defined as Absence of Any Grade 2 or Worse Rash (Study II)

Timeframe: At 4 weeks

Trial details

NCT IDNCT01867294

SponsorAcademic and Community Cancer Research United

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-05-09

Results submitted2018-08-22

View on ClinicalTrials.gov More Advanced Malignant Neoplasm trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Patients Reporting a Grade 2+ Adverse Event Attributed to Spironolactone (Study I)

Timeframe: At 8 weeks

Incidence of Truncal/Extremity Rash of Any Grade in Patients in the Spironolactone Arm (Study I)

Timeframe: At 4 weeks

Percentage of Patients in the Spironolactone Arm Who Complete the 4-week Study Intervention (Study I)

Timeframe: At 4 weeks

Efficacy of the Spironolactone Treatment to Prevent/Attenuate Rash From EGFR Inhibitors in This Patient Population Defined as Absence of Any Grade 2 or Worse Rash (Study II)

Timeframe: At 4 weeks